FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 5196077
·
Received November 2, 2015
Report
- Report Number
- 2531779-2015-39624
- Event Type
- Malfunction
- Date Received
- November 2, 2015
- Report Date
- October 19, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/19/2015 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE PEELING AND PUNCTURED. EVALUATION REVEALED ALL KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED KEYPAD BUTTON CONTACT CONTAMINATION UNDER ALL CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 10/19/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725308 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |